Philips Brilliance iCT CT Systems Recalled for Software Defects
Philips is recalling Brilliance iCT CT systems due to software issues affecting scan functions and safety features.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device with software defects affecting safety features like exam stop and tube overheat, but no injuries or illnesses are reported in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 559 Brilliance iCT SP (Model 728311) and Brilliance iCT (Model 728306) Computed Tomography X-ray systems. These devices were distributed worldwide, including nationwide in the United States.
The recall is due to numerous software issues in version 4.1.6. These issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error messages, length of acquisition, and image volume functions.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve these software issues.
The recalled product
- Product
- Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 559
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Philips Medical Systems (Cleveland) Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Philips Medical Systems (Cleveland) Inc
See all →- HighRadiation planning software recalled over image errors in three patient orientations
FDA (Devices) · 2025-09-24
- HighPinnacle 3 radiation planning software may miscalculate stopping power ratio
FDA (Devices) · 2025-08-13
- HighPinnacle3 Radiation Therapy Planning System dose-calculation software error
FDA (Devices) · 2022-09-21
- SeverePhilips Forte Gamma Camera System Recalled Due to Detector Falling Hazard
FDA (Devices) · 2019-11-13
- SeverePhilips Recalls Forte Gamma Camera Systems Due to Detector Fall Risk
FDA (Devices) · 2019-11-13
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModeratePhilips Brilliance iCT SP CT Scanner Software Recall
FDA (Devices) · 2016-08-17
- ModeratePhilips Brilliance iCT Recalled for Software Performance Issues
FDA (Devices) · 2016-08-17
- HighPhilips Brilliance iCT SP CT Systems Recalled for Software Defects
FDA (Devices) · 2015-08-05
- HighPhilips Brilliance iCT CT Systems Recalled for Software and Hardware Defects
FDA (Devices) · 2015-08-05
- ModeratePhilips Brilliance iCT SP CT Systems Recalled for Software Error
FDA (Devices) · 2016-04-20
- HighPhilips Brilliance iCT Computed Tomography System Software Defect Recall
FDA (Devices) · 2014-12-24